A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)

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Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle).

Carfilzomib

Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle).

Carfilzomib

Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).

Total

Total of all reporting groups

Baseline Measures

Best Supportive Care

Carfilzomib

Total

Overall Participants Analyzed [Units: Participants]

158

157

315

Age [Units: Years]Mean (Standard Deviation)

65.5 (8.02)

63.3 (10.71)

64.4 (9.50)

Sex: Female, Male [Units: Participants]Count of Participants

Female

62 39.2%

75 47.8%

137 43.5%

Male

96 60.8%

82 52.2%

178 56.5%

Race/Ethnicity, Customized [Units: Participants]

American Indian or Alaska Native

0

0

0

Asian

4

1

5

Native Hawaiian or Other Pacific Islander

0

0

0

Black or African American

1

1

2

White

148

151

299

Other

5

4

9

Region [Units: Participants]

Europe

138

140

278

Non-Europe

20

17

37

Number of Prior Regimens to Treat Multiple Myeloma [Units: Participants]

Overall Survival [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively. ]

Progression-free Survival [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

Overall Response [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

Clinical Benefit Response [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

Disease Control [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.